Les missions du poste
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.
Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.
We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.
About the Job
At Excelya, we embody Audacity, Care, and Energy in all that we do. We offer a dynamic and inclusive environment where innovation and collaboration drive success.
The Clinical Monitoring Lead will oversee and coordinate clinical monitoring activities to ensure the successful and compliant execution of clinical trials. This role involves leading CRA teams, ensuring quality standards are met, and maintaining effective communication with stakeholders to implement best clinical practices.
Main Responsibilities
- Oversee and coordinate CRO clinical and site management activities throughout study startup, conduct, and closeout phases.
- Ensure efficient and highquality study startup by reviewing feasibility assessments, supporting site selection, and verifying the timely collection of essential regulatory and ethics documents prior to site initiation.
- Support and ensure completion of sponsorspecific clinical tasks within EDC, CTMS, and other study systems according to defined timelines.
- Support CRO teams in CRA training on studyspecific operational activities and participate in the preparation and organization of investigator and monitor meetings.
- Support Global Clinical Project Managers in defining detailed clinical timelines and study milestones, ensuring delivery to the highest quality standards.
- Prepare or contribute to monitoring oversight documentation, including monitoring plans, oversight plans, and clinical monitoring metrics.
- Customize, monitor, and follow sitelevel KPIs and KRIs according to the monitoring oversight plan.
- Review and validate key clinical study documents prepared by CROs (monitoring plans, study manuals, operational documents).
- Review site visit reports (all or a defined sample) and ensure timely followup and resolution of issues identified by CRAs.
- Coordinate and manage CRO relationships, providing operational guidance to CRO CRAs and CTLs as needed.
- Perform comonitoring visits and maintain direct contact with investigator sites to proactively identify and resolve study issues.
- Participate in ongoing clinical data reviews in collaboration with crossfunctional study teams.
- Ensure accurate and timely reporting in CTMS, with continuous quality checks.
- Ensure study samples and protocolrequired assessments are coordinated effectively between sites, CROs, vendors, and internal departments.
- Contribute to TMF quality reviews throughout the study and lead final TMF checks prior to study archiving.
- Support audit and inspection readiness activities, including site preparation and followup of findings.
- Act as a backup to the Clinical Research Manager when required.
- Represent the sponsor at investigator sites and maintain strong, professional investigator relationships.
Le profil recherché
WhyJoinUs?
AtExcelya,wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare.
Here'swhatmakesusunique-
Weareayoung,ambitioushealthcompanyrepresenting900Excelyates,driventobecomeEurope'sleadingmid-sizeCROwiththebestemployeeexperience.Ourone-stopproviderservicemodel-offeringfull-service,functionalserviceprovider,andconsulting-enablesyoutoevolvethroughdiverseprojects.Workingalongsidepreeminentexperts,youwillhelpimprovescientific,operational,andhumanknowledgetoenhancethepatient'sjourney.
Excellingwithcaremeansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential,allowingyoutocontributefullytooursharedmission.
About You
- Experience as a Lead CRA or in a clinical monitoring leadership role coordinating international studies.
- Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
- Excellent communication, organizational, and leadership skills.
- Ability to multitask, prioritize, and manage teams in a fast-paced environment.
- Degree in life sciences, pharmacy, nursing, or related field.
- Fluency in English and French is preferred.